Commission proposes largest EU Pharma industry review in decades
On 26 April, the proposal for the pharma package review was issued by the Commission. The revision is the first major review of the pharmaceutical legislation since 2004 and aims to adapt the European pharmaceutical legislation to the needs of the 21st century. The reform aims to ensure more timely and equal access, lower burdens on companies, and lower healthcare costs.
The review encompasses two legislative proposals, a Directive, and a Regulation, which will serve as the EU regulatory framework for medicines, including those for rare diseases and children. The Directive outlines the requirements for authorisation, monitoring, labelling, and regulatory protection for all medicines authorised at the EU and national levels. The Regulation contains specific rules for medicines authorised at the EU level, particularly for highly innovative ones. It governs the coordination of critical shortages and security of the supply of critical medicines, as well as the European Medicines Agency (EMA). In addition, a Council Recommendation on antimicrobial resistance (AMR) is part of the reform. Lastly, a Communication accompanies these legislative proposals and Council recommendation. In total, the proposal has 400 articles and 500 pages.
Shortly after the publication, a Commission press conference was held with Commissioner for Health Stella Kyriakides and Margaritis Schinas, Commission Vice-President for Promoting the European Way of Life, as well as an exchange between the European Parliament’s responsible ENVI Committee and Kyriakides. Given the length of the proposal, discussions on 26 April mostly stayed on the surface. During both deliberations, Commissioner Kyriakides stressed the importance of availability, affordability, and access for all citizens, which is referred to as “triple A”, with no differences between Member States or citizens.
The Commission pointed out that the proposal provides the most generous Regulatory Data Protection with a maximum of twelve years of market exclusivity for Reference Products (RP), eight years of Regulatory Data Protection (RDP), an additional two years for the launch of medicines to all EU Member States, six months extra for those that address unmet medical needs, six months extra if comparative clinical trials are conducted, and one additional year if the medicine can treat other diseases. For medicines for rare diseases, standard market exclusivity will be nine years. An additional year will be available if they address high unmet medical needs, another year if they launch in all 27 Member States and an extra two years for the development of new therapeutic indications for an already authorised orphan medicine.
Additionally, the proposal includes a Critical Medicines List that requires biopharmaceutical companies to provide a shortage prevention plan. The Commission plans on issuing the list by the end of this year. The proposal addresses sustainability in medicines and increased transparency on public funding for the development of medicines. The Commissioner marked the Commission’s commitment to increasing clinical trial data. The proposal, further, includes transferable exclusivity vouchers for antimicrobial resistance (AMR).
MEPs tentatively welcomed the legislation, but acknowledged they required time to assess the proposals in more detail. The EPP was positive about the improvements made to the proposal since the earlier leak and welcomed the idea of transferable vouchers for AMR. However, they expressed concerns about shortages. The S&D representatives found the proposal long-awaited and called for more transparency, especially regarding research. They also asked about how shortages will be addressed and whether there will be an EU stockpiling system. The Renew group was positive about the incentives put forward but demanded more efforts for transparency and expressed concerns about the accumulation of years and vouchers. The Greens were positive about the proposal’s environmental outlook but strongly criticised the voucher system.
In response, the Commissioner emphasized that access was the key priority of the review. She announced that there will be an early notification of shortages. The Commissioner is committed to increasing clinical trial data and expressed that the suggested voucher system was deemed effective as a result of a risk assessment. Discussions were held on rare diseases and planned changes to the structure of the EMA.
Concerning the adoption of the files, Schinas said he is hoping for an outline of an agreement by the end of the mandate in 2024. In the next steps, Parliament and Council will need to find their negotiating mandates.